Pooled analysis of data from phase I and II studies used to evaluate AE of interstitial lung disease/pneumonitis associated with T-Dxd
MONDAY, Aug. 22, 2022 (HealthDay News) — For patients receiving trastuzumab deruxtecan (T-DXd) monotherapy, the incidence of adjudicated drug-related interstitial lung disease (ILD)/pneumonitis is 15.4 percent, according to a study published online Aug. 11 in ESMO Open.
Charles A. Powell, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a pooled analysis of nine phase I and II T-DXd monotherapy studies to describe drug-related ILD/pneumonitis. A total of 1,150 patients (44.3, 25.6, 17.7, 9.3, and 3.0 percent with breast, gastric, lung, colorectal, and other cancer, respectively) were included in the analysis (median treatment duration, 5.8 months; median of four prior lines of therapy).
The researchers found that the incidence of adjudicated drug-related ILD/pneumonitis was 15.4 percent overall (grade 5, 2.2 percent); a majority of patients experienced low-grade events (grade 1 or 2, 77.4 percent). Most patients (87.0 percent) had their first event within 12 months of the first dose of T-DXd (median, 5.4 months). For 53.2 percent of events, adjudicated ILD/pneumonitis onset occurred earlier than identified by investigators (median difference in onset, 43 days). Baseline factors potentially associated with an increased risk for adjudicated drug-related ILD/pneumonitis included age younger than 65 years, enrollment in Japan, T-DXd dose >6.4 mg/kg, oxygen saturation <95 percent, moderate/severe renal impairment, lung comorbidities, and more than four years since the initial diagnosis.
“The monitoring, diagnosis, and management of ILD/pneumonitis is an area of continuing improvement; to this end, new toxicity guidelines have been implemented, and education has been provided to health care providers and patients,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including AstraZeneca and Daiichi Sankyo, which developed and commercialized T-DXd and funded the study.
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